Patents on Small-Molecule Drugs Approved by the US Food and Drug Administration, 1990-2019.
Patent portfolios for FDA-approved small-molecule drugs expanded from an average of 2.1 to 6.9 patents per drug between 1990 and 2019, mainly due to nonprimary patents.
- Why it matters: This growth in patent holdings can delay generic drug entry, keeping drug prices high and limiting competition, which impacts healthcare affordability and access.
- What they did: The study analyzed 1,981 drugs and 10,940 patents, focusing on the number, types, and enforcement of patents, revealing a significant rise in nonprimary patents over three decades.
- The result: The predominance of nonprimary patents extended market exclusivity by an average of 6.1 years and was frequently enforced against generics, complicating competition and sustaining high drug prices.